ASCO26: In Vivo Oncology Approaches Continue to Show Promise

Why It Matters

In‑vivo CAR‑T sidesteps the costly, time‑intensive manufacturing of ex‑vivo products, offering faster, scalable options for patients and investors. The promising trial outcomes signal a potential shift in how biotech firms develop and commercialize next‑generation immunotherapies.

Key Takeaways

• Kelonia's KLN‑1010 achieved 100% ORR in 18 multiple myeloma patients
• Lilly's pending $7 bn acquisition targets in‑vivo CAR‑T platform
• Strand's EverScript LNP system generated functional CAR‑T cells in animal models
• Immunocore's brenetafusp showed 14.3‑month median OS in advanced melanoma
• In‑vivo cell therapies could bypass ex‑vivo manufacturing bottlenecks

Pulse Analysis

The surge of in‑vivo CAR‑T data at ASCO underscores a broader industry pivot toward off‑the‑shelf immunotherapies. Traditional ex‑vivo CAR‑T requires patient‑specific cell extraction, engineering, and reinfusion—a process that can take weeks and cost upwards of $400,000 per treatment. By delivering gene‑editing payloads directly into the body, in‑vivo platforms promise to compress timelines, reduce logistical complexity, and expand access to patients who cannot wait for bespoke manufacturing. This paradigm shift aligns with investors’ appetite for scalable biotech models that can address both hematologic and solid‑tumor indications.

Lilly’s partnership with Kelonia illustrates how major pharma is betting on this technology. The Phase I inMMyCAR trial reported a 100% overall response rate and deep, MRD‑negative remissions, outcomes that exceed many ex‑vivo benchmarks. The $7 bn acquisition, including a $3.25 bn upfront cash component, reflects confidence that KLN‑1010 can become a flagship product in the crowded multiple myeloma market. Meanwhile, Strand Therapeutics leveraged a $135 million capital raise to showcase its EverScript circular RNA platform, which achieved functional CAR‑T cell generation in non‑human primates and early human data. Such preclinical validation positions Strand for rapid progression into pivotal trials and potential partnership or licensing deals.

Immunocore’s brenetafusp adds another layer to the in‑vivo narrative, delivering a T‑cell receptor‑based therapy that achieved a median overall survival of 14.3 months in advanced melanoma—a disease where checkpoint inhibitors have plateaued. The upcoming Phase III comparison against standard nivolumab regimens could cement brenetafusp as a viable first‑line option, especially for patients resistant to PD‑1 blockade. As regulatory agencies become more familiar with gene‑delivery modalities, the path to approval may accelerate, prompting a wave of M&A activity and venture capital inflows. For clinicians, the promise of off‑the‑shelf, in‑vivo cell therapies could translate into earlier intervention, broader eligibility, and ultimately, improved survival outcomes across oncology.